DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 07/28/26 has been entered. Claim 1 has been amended. Claims 4, 6-9, 11, and 14-15 are in the original/ previously presented form. Claims 5, 12-13 are withdrawn. Claims 2-3 and 10 are cancelled. Thus, claims 1, 4, 6-9, 11, and 14-15 remain pending in the application. There were no objections or 112 rejections previously set forth in the Non-Final Office Action mailed 03/30/26. Therefore, there are no objections or 112 rejections withstanding.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the:
Outer surface of the nipple receiving portion engages each of the first and second openings as in at least claim 1. This drawing objection could be rectified by including a numeral for the outer surface of the nipple receiving portion in [0107] of the current Application’s PGPUB and placing said numeral on the elected embodiment drawing of FIG. 24C (see the 112b rejection below for further explanation)
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4, 6-9, 11, and 14-15 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the amended limitation in claim 1 lines 11-13 recite “wherein the outer surface of the nipple receiving portion engages each of the first and second openings and mates with and seals against each of the first and second openings”. In view of Applicant remarks and disclosure, it is unclear to the examiner what “outer surface of the nipple receiving portion” engages “each of the first and second openings” and “mates with” and “seals against” each of the first and second openings.
Applicant has elected the embodiment of FIG. 24C (a modified figure is provided below), see “Response to Restriction requirement” dated 03/11/24. In the elected embodiment, Applicant shows the second opening of the second part merely circumferentially extending around the outer surface of the nipple receiving portion (See figure ‘Elected embodiment FIG. 24C’ below and [0107] of Applicant disclosure).
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Therefore, the outer surface of the nipple receiving portion (as interpreted and shown in the figure above) does not touch the second opening.
However, on pages 5-6 of Applicant Remarks filed 07/28/26, Applicant argues that both prior art references, Pollen and Silver, fail to disclose the limitation “wherein the outer surface of the nipple receiving portion engages each of the first and second openings and mates with and seals against each of the first and second openings” because the outer surface of the nipple receiving portion does not touch the second opening. Thus, because Applicant structure of the outer surface of the nipple receiving portion also does “not touch” the second opening, it is unclear to the examiner what “outer surface” of the nipple receiving portion engages the “second opening” to mate and seal against the “second opening” in the manner that is argued in Applicant remarks.
Thus, the examiner further consulted Applicant disclosure for information regarding the outer surface of the nipple receiving portion. In [0107] of the current Application’s PGPUB, it is disclosed “The outer surface of the nipple receiving portion 468 is sized and shaped to seal with an opening formed in the first part 462 and a generally circular base 469 of the funnel 466 seals with an opening in the second part 464,”. Therefore, it seems that the outer surface of the nipple receiving portion seals against the first part, but the outer surface/ generally circular base 469 of the funnel 466 is the structure that mates and seals with the opening of the second part (see ‘Modified FIG. 24C’ below for visual clarity).
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Because there is no numeral for the outer surface of the nipple receiving portion depicted in the drawing of the elected embodiment (see drawing objection above), the examiner relies mainly on the disclosure in [0107] to decipher the location of the outer surface of the nipple receiving portion. Although [0107] calls the base 469 a part of the funnel, perhaps Applicant intends the recitation of “the outer surface of the nipple receiving portion” to encompass the entire top surface of the funnel (see ‘Modified FIG. 24C: another interpretation’)?
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Thus, the outer surface of the nipple receiving portion would encompass the nose-shaped of 468 that engages/mates/seals with the first opening AND the rim of the base that engages/mates/seals with the second opening (as in [0107]).
The 112b rejection must be addressed because the newly amended limitation borders on a 112a new matter rejection because it appears that there is only support for the outer surface of the funnel engaging/mating/sealing with the second opening and the disclosure lacks support for an outer surface of the nipple receiving portion engaging/mating/sealing the second opening (Applicant could overcome the 112b rejection by properly identifying on the drawings the structure of the outer surface of the nipple receiving portion that engages/mates/seals against both the first and second openings).
For purposes of examination, the examiner interprets that either the outer surface of a nose-shaped nipple receiving portion or the outer surface/rim of a funnel structure would meet the limitation as claimed of “wherein the outer surface of the nipple receiving portion engages each of the first and second openings and mates with and seals against each of the first and second openings”.
Due to claim dependency from claim 1, claims 4, 6-9, 11, and 14-15 are subsequently rejected under 112b.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 6-7, and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pollen et al. (U.S. PGPUB No. 2015/0217033), hereinafter Pollen.
Regarding claim 1, Pollen discloses a reusable container assembly for a breast pump system (see FIG. 36 and [0073-0074]: FIG. 36 shares several structures of other embodiments, just with additional features such as enhanced valve design 28d. Therefore, other figures and paragraphs will be referenced that describe same structural elements of FIG. 36), comprising:
a first part (26);
a second part (24’) sized and shaped to seal with (as seen in FIG. 36 and [0042]: no milk leaks from device even if device is tipped over and therefore the parts must be sealed. See also [0050]: at least opening 82 of second part seals around first part 26 as seen in FIG. 5) the first part (26), the second part (24’) including a second part breast facing outer surface (outer rim of 24’, see [0044] and ‘Modified FIG. 27’ below); and
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a funnel (22) sized and shaped to receive a breast (34, see FIG. 3 and [0043]), the funnel (22) including a nipple receiving portion (32, see FIG. 5) mating with the first (22) and second parts (24’) to complete a sealed reusable container assembly (see [0042-0044]) that stores milk (14), the funnel (22) including a funnel breast facing outer surface (30, see FIG. 5 and [0043]);
wherein the nipple receiving portion (32) includes an outer surface (as interpreted under 112b above, the outer surface of the nipple receiving portion encompasses the surface of the nose portion 32 and/or the rim of funnel 22, as outlined in ‘Modified FIG. 5’ below)
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and the first part (26) includes a first opening (see ‘Modified FIG. 5’ above and [0044]) and the second part (24’) includes a second opening (see ‘Modified FIG. 5’ above), wherein the outer surface of the nipple receiving portion (as interpreted under 112b above, the outer surface of the nipple receiving portion encompasses the surface of the nose portion 32 and/or the rim of funnel 22, as outlined in ‘Modified FIG. 5’ above) engages each of the first (first opening engaged by nose portion of outer surface of nipple portion as shown by the arrow in FIG.5. see engagement in FIG. 4 and described in [0043-0044] & [0046-0047]) and second openings (second opening engages rim of outer surface of nipple receiving portion in ‘Modified FIG. 5’ above. See also FIG. 4 and [0043-0044] & [0046-0047]) and mates with and seals against each of the first and second openings (see FIG. 4 & 36, and [0043-0044] & [0046-0047]), and wherein milk (14) is stored within (see [0044]: milk storage chamber 42—not labeled in FIG. 36. See milk chamber 42 labeled in FIG 4 for visual reference. See [0073-0074]. FIG. 36 same as other embodiments with enhanced valve design 28d, instead of 28 as shown in FIG. 4 and described in [0044]) the first part (26) and the second part (24’) and the second part breast facing outer surface (outer rim surface of 24’, see ‘Modified FIG. 36’ below or ‘Modified FIG. 27’ above)
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and the funnel breast facing outer surface (30, see ‘Modified FIG. 36’ above) cooperate to form a contiguous breast facing outer surface of the breast pump system (see “cooperation” surfaces shown by the outlines in black in ‘Modified FIG. 36’ above. Surfaces are “contiguous” by intersection).
Regarding claim 4, Pollen discloses the reusable container of claim 1, and Pollen further discloses wherein the container assembly (see FIG. 36) is longitudinally split (see exploded view in at least FIG. 5 showing longitudinal splitting of assembly parts) to define the first (26) and second (24’) parts.
Regarding claim 6, Pollen discloses the reusable container of claim 1, and Pollen further discloses wherein the second part (24’, see FIG. 36) includes an oval opening (formed through the second part breast facing outer surface, see ‘Modified FIG. 36’ above) and the funnel (32) includes an oval shaped base (40, see FIG. 1 and [0044]) that mates with the oval opening (see [0044]: 24 connects to flange 40 such as shown by arrows in FIG. 5).
Regarding claim 7, Pollen discloses the reusable container of claim 1, and Pollen discloses further comprising a removable plug (28d, see [0073]:28d is removable to form a ‘cleaning’ state of the device) that defines a connection (190, see [0073]) to a conduit (146d) that delivers fluid to the container assembly (see [0044]: milk flows from first part 22 into chamber 46 formed by valve 28 and then into collection chamber 42. Therefore, milk must also flow through/ be delivered by connection 190 and conduit 146d in order to reach the chamber formed within valve 28.)
Regarding claim 9, Pollen discloses the reusable container of claim 1, and Pollen further discloses wherein the first (26, see FIG. 36) and second parts (24’) are removably sealed to each other (see [0043-0044] and removable as seen in FIG. 4 and 5).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silver et al. (U.S. PGPUB No. 2010/0121267), hereinafter Silver.
Regarding claim 1, Silver discloses a reusable container assembly for a breast pump system (see [0003]), comprising:
a first part (1350, see FIG. 37);
a second part (1386) sized and shaped to seal with (see [0224]) the first part (1350), the second part (1386) including a second part breast facing outer surface (surface of 1386 facing funnel, see ‘Modified FIG. 37’ below); and
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a funnel (1366) sized and shaped to receive a breast (see [0007]: inner shield receives breast and see [0222-0223]: 1366 is inner shield in embodiment of FIG.37), the funnel (1366) including a nipple receiving portion (1368) mating with the first (1350, see [0221-0224]) and second parts (1386, see [0224]: 1386 set into rim 1382) to complete a sealed reusable container assembly that stores milk (see [0015], [0028], [0221], and [0225]), the funnel (1366) including a funnel breast facing outer surface (leftward/ backside surface of 1382 as outlined in ‘Modified FIG. 37’ above);
wherein the nipple receiving portion (1368) includes an outer surface (as interpreted under 112b above, the outer surface of the nipple receiving portion encompasses the surface of the nose portion 1368 and/or the rim of funnel 1366, as seen in ‘Modified FIG. 37’ above) and the first part (1350) includes a first opening (internal opening into 1358 from the funnel-facing side comprising inner sidewall of 1358 and face of rim 1362 facing in funnel direction) and the second part (1386) includes a second opening (see ‘Modified FIG. 37’ above), wherein the outer surface of the nipple receiving portion (as interpreted under 112b, the outer surface of the nipple receiving portion encompasses the surface of the nose portion 1368 and/or the rim of funnel 1366, as seen in ‘Modified FIG. 37’ above) engages each of the first (nose portion of the outer surface of the nipple receiving portion engages inner sidewall of 1358, see [0223]: 1368 inserted into 1350 within inner sidewall 1358. And see [0222]: rim of 1366 engaging 1362a of the first opening) and second openings (outer surface of nipple receiving portion of rim 1366 holds second part/second part openings, see [0224]) and mates with and seals against each of the first (see [0222-0223]: mating and sealing against 1362a) and second openings (see [0224]: 1386 set into rim 1382), and wherein milk is stored within the first part and the second part (see [0225]: milk flows through first and second parts and stores milk that is prevented from spilling) and the second part breast facing outer surface (surface of 1386 facing funnel) and the funnel breast facing outer surface (see ‘Modified FIG. 37’ above) cooperate to form a contiguous breast facing outer surface of the breast pump system (see [0224]: 1382 snap fit into 1362 and thus forms contiguous surface and this structure aligns with current invention disclosure in FIG. 24C and [0107]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Silver (U.S. PGPUB No. 2010/0121267).
Regarding claim 8, Silver discloses the reusable container of claim 1, but in the embodiment of FIG. 36, Silver is silent to “wherein the first and second parts are welded together.”
However, in another embodiment (see FIG. 9 and [0111]), Silver teaches a first part (292A) and a second part (292B), wherein the first and second parts are welded together (see [0111]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second parts disclosed in Silver (FIG. 36) to be welded together as taught by Silver (FIG. 9) for the purpose of forming the first and second parts as an integral unit (see [0111]), thus achieving “wherein the first and second parts are welded together.”
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Pollen as applied to claim 1 above, and further in view of Garbez et al. (U.S. PGPUB No. 2018/0008758), hereinafter Garbez.
Regarding claim 11, Pollen discloses the reusable container of claim 1, but Pollen is silent to wherein the second part “includes a scalloped edge that is sized and shaped to mate with a second scalloped edge of the first part.”
However, Garbez teaches a reusable container assembly for a breast pump system (see FIG. 5) comprising a first part (32) and a second part (20), wherein the second part (20) includes a scalloped edge (38, see [0026]) that is sized and shaped to mate with (see [0026]: edges engaged to form snap-fit connection) a second scalloped edge (34) of the first part (32).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second part edges disclosed in Pollen to include scalloped edges as taught by Garbez for the purpose of forming a snap-fit engagement at the outer rims of the first and second part (see [0026]), thus achieving wherein the second part “includes a scalloped edge that is sized and shaped to mate with a second scalloped edge of the first part.”
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pollen as applied to claim 1 above, and further in view of Quay (U.S. PGPUB No. 2002/0072702).
Regarding claim 14, Pollen discloses the reusable container of claim 1, but Pollen is silent to “further comprising a locking ring sized and shaped to be rotated about the nipple receiving portion.”
However, Quay teaches a breast pump assembly for withdrawing fluid from a breast (see [0020]) including a locking ring (109, see FIG. 11) sized and shaped to be rotated (see [0136]: 109 is rotatable received onto 22 by, in example, see [0135] threadable engagement) about a nipple receiving portion (22 wherein nipple 16 is received).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the nipple receiving portion disclosed in Pollen to include the rotatable locking ring as taught in Quay for the purpose of obtaining a removable connection between components or to adjustably mount the device to ensure contact with the breast fluid (see [0136]), thus achieving “further comprising a locking ring sized and shaped to be rotated about the nipple receiving portion.”
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Pollen as applied to claim 1 above, and further in view of Vogelin et al. (U.S. PGPUB No. 2007/0179439), hereinafter Vogelin.
Regarding claim 15, Pollen discloses the reusable container of claim 1, and Pollen discloses further comprising a fitment assembly (28d, see FIG. 36) including one or more components (see [0073-0074]: 28d/ 148d of valve attached to assembly 146d), but is silent to the one or more components “formed from layers of TPE/LDPE/TPE or similar variations so that the TPE parts are utilized as sealing material with mating parts.”
However, Vogelin teaches a breast pump assembly with a container (see Fig. 2) wherein at least one part, particularly a valve body (7), is formed of TPE (see [0062]).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the valve of the fitment assembly as disclosed by Pollen to be made from TPE as taught by Vogelin for the purpose of reducing the repeated use duration by choosing a non-autoclavable material ([0062]: TPE is a non-autoclavable material and [0023-0024]), thus configuring the breast shield set of the device for repeated use of only a few times (see [0004]: breast shield set should only be used repeatedly a few times for hygiene reasons and to drive down the manufacturing cost of some of the assembly components), thus achieving the fitment assembly including one or more components “formed from layers of TPE/LDPE/TPE or similar variations so that the TPE parts are utilized as sealing material with mating parts.”
Response to Arguments
Applicant's arguments filed 07/28/26 have been fully considered but they are not persuasive.
On pages 5-6, Applicant argues that both Pollen and Silver fail to disclose the limitation “wherein the outer surface of the nipple receiving portion engages each of the first and second openings and mates with and seals against each of the first and second openings” because the outer surface of the nipple receiving portions do not touch the second openings. However, in view of the 112b rejection above, these arguments are not persuasive because it is unclear what surface the “outer surface of the nipple receiving portion” is referring to in at least this portion of claim 1.
Therefore, the examiner maintained the references under the 112b interpretation of the claim language above.
No further arguments were presented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
